Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R)...(ns and symptoms of acute agitation. In M...),Health

Date:7/24/2008

ns and symptoms of acute agitation. In March 2007, Alexza announced positive initial results from a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial in 129 patients in an in-patient clinical setting. The 10 mg dose of AZ-004 met the primary endpoint of the clinical trial, which was a statistically significant reduction in the measure of agitation from baseline to the 2-hour post-dose time point, as compared to placebo. The 10 mg dose of AZ-004 also exhibited a rapid onset of effect, with a statistically significant improvement in the PEC scores at 20 minutes post-dose, as compared to placebo. The effectiveness of the AZ-004 10 mg dose was sustained throughout the 24-hour study period, as compared to placebo.

About Alexza Pharmaceuticals, Inc.

Alexza Pharmaceuticals is an emerging specialty pharmaceutical company focused on the development and commercialization of novel, proprietary products for the treatment of acute and intermittent conditions. The Company's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that allows rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.

Alexza has six product candidates in clinical development. Alexza's lead program, AZ-004 (Staccato loxapine) for the treatment of acute agitation in schizophrenic or bipolar disorder patients, is in Phase 3 testing and completed the enrollment of its first Phase 3 clinical trial in June 2008. AZ-001 (Staccato prochlorperazine) for the acute treatment of migraine headaches has completed Phase 2 testing. AZ-104 (Staccato loxapine) for the acute treatment of migraine headaches and AZ-002 (Staccato alprazolam) for the acute treatment of panic attacks associated with panic disorder are in Phase
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SOURCE Alexza Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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